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Background: The optimal duration of clopidogrel use for prevention of stent thrombosis with drug-eluting stent (DES) use is uncertain. Our objective was to determine whether the planned duration of clopidogrel at the time of percutaneous coronary intervention affected patient outcomes., Methods: We analyzed data from 2,980 patients who underwent percutaneous coronary intervention in the Melbourne Interventional Group registry who had 12-month follow-up. We compared outcomes at 30 days and 12 months according to planned duration of clopidogrel use., Results: Twelve-month mortality was significantly lower in patients with a DES with a longer (>or=12 months) planned duration of clopidogrel when compared with a shorter (or=12 months (log rank P = .017), and the propensity score-adjusted odds ratio was 0.59 (95% confidence interval 0.35-0.99, P = .04). Premature cessation of clopidogrel in DES patients was documented in 5.2% of patients alive at 30-day follow-up, and these patients had increased 12-month mortality (10.6% vs 1.4%, P < .0001) and major adverse cardiac events (22.4% vs 12.0%, P = .005)., Conclusions: These data suggest that in patients treated with DES, longer (>or=12 months) planned duration of clopidogrel results in reduced 12-month mortality and that premature cessation of clopidogrel results in significantly higher event rates. Randomized studies are urgently needed to address this issue.

Background: The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations., Study Design: In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 x 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration., Summary: The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.

Background: Single nucleotide polymorphisms of vitamin K epoxide reductase complex subunit 1 (VKORC1) was reported to have association with arterial vascular disease. We investigated whether single nucleotide polymorphism of VKORC1 +2255 is associated with clinical outcomes among patients who underwent drug-eluting stent (DES) implantation., Methods: We prospectively collected genomic DNA in patients who underwent DES deployment from September 2003 to December 2006 and compared clinical outcomes according to their VKORC1 genotype at the locus + 2255 (rs 2359612). The primary end point was composite of atherothrombotic events (cardiac death, myocardial infarction, and nonhemorrhagic stroke)., Results: Mean follow-up duration was 631 +/- 251 days. Genotyping was completed in 764 cases (TT genotype [n = 640, 83.8%] vs non-TT [CC or CT] genotype [n = 124, 16.2%]). Non-TT group showed more composite events than TT group (7.3% vs 3.0%, P = .032). In the Cox regression analysis, non-TT genotype of VKORC gene was a significant predictor of atherothrombotic events (hazard ratio 2.56, 95% confidence interval 1.14-5.78). In the event-free survival analysis, non-TT group also showed significantly poorer cardiovascular events-free survival rate than TT group (P = .02)., Conclusions: VKORC1 genotype is associated with cardiovascular events in patients with DES implantation, suggesting the role of coagulation system.

Background: The long-term incidence of stent thrombosis (ST) and complications after sirolimus-eluting stents (SES) implantation is still a matter of debate., Method: We conducted a systematic follow-up on the day of their 5-year SES implantation anniversary, in a series of consecutive real-world patients treated with a SES. The use of SES implantation was not restricted to "on-label" indications, and target lesions included in-stent restenosis, vein graft, left main stem locations, bifurcations, and long lesions. The Academic Research Consortium criteria were used for ST classification., Results: Three hundred fifty consecutive patients were treated with SES between April and December 2002 in 3 Swiss hospitals. Mean age was 63 +/- 6 years, 78% were men, 20% presented with acute coronary syndrome, and 19% were patients with diabetes. Five-year follow-up was obtained in 98% of eligible patients. Stent thrombosis had occurred in 12 patients (3.6%) [definite 6 (1.8%), probable 1 (0.3%) and possible 5 (1.5%)]. Eighty-one percent of the population was free of complications. Major adverse cardiac events occurred in 74 (21%) patients and were as follows: cardiac death 3%, noncardiac death 4%, myocardial infarction 2%, target lesion revascularization 8%, non-target lesion revascularization target vessel revascularization 3%, coronary artery bypass graft 2%. Non-TVR was performed in 8%., Conclusion: Our data confirm the good long-term outcome of patients treated with SES. The incidence of complications and sub acute thrombosis at 5 years in routine clinical practice reproduces the results of prospective randomized trials.

Objectives: We investigated the hypothesis that biological aspirin "resistance" may often be related to noncompliance in patients undergoing coronary stenting., Background: Premature discontinuation of antiplatelet therapy has been identified as a major risk factor for stent thrombosis and prior aspirin withdrawal has been associated with poor prognosis after acute coronary syndrome., Methods: We prospectively investigated the occurrence of aspirin noncompliance in 136 consecutive patients undergoing coronary stenting receiving aspirin 75 mg daily. We analyzed posttreatment maximal intensity of arachidonic acid-induced platelet aggregation (AA-Ag) during hospitalization after controlled intake of aspirin and 1 month after hospital discharge. After 1 month, all "nonresponders" received controlled aspirin 75 mg and assessment of response was repeated. Aspirin nonresponse was defined by AA-Ag >30%., Results: During inhospital period, the range of AA-Ag varied from 0% to 34% with a mean value of 7.5% +/- 10%, and 4 patients (3%) were classified as nonresponders. One month after discharge, AA-Ag of the population was significantly higher than during the hospital phase (15.3 +/- 23 vs 7.5 +/- 10%, P = .0004), and 19 patients (14%) were identified as nonresponders. After controlled administration of aspirin, all but one of these nonresponders became responders and were identified as patients with noncompliance rather than biological resistance., Conclusion: Aspirin resistance is rare in compliant patients using methods that directly indicate the degree of platelet cyclooxygenase inhibition. More than 10% of patients receiving aspirin for coronary stenting are noncompliant for aspirin therapy during the first month after stenting. These results suggest a need for improved education of these patients.

Background: Kidney failure (stage 5 chronic kidney disease [CKD]) is an independent risk factor for stent thrombosis (ST). Moderate (stage 3-4) CKD and proteinuria are both associated with adverse cardiovascular events, including worse outcomes after myocardial infarction (MI). Whether moderate CKD and proteinuria increase the risk of ST after MI is not known. This study evaluated the risk of ST associated with moderate CKD and dipstick proteinuria., Methods: We retrospectively analyzed clinical and laboratory data from 956 non-stage 5 CKD patients who were admitted with MI and received intracoronary stenting. Clinical follow-up was collected at 1 year for definite or probable ST, as well as for all-cause mortality, nonfatal MI or death, and target vessel revascularization or coronary artery bypass graft surgery., Results: After adjustment for multiple clinical and biochemical covariates, patients with both estimated glomerular filtration rate (GFR) of 15 to 59 mL min(-1) 1.73 m(-2) and > or =30 mg/dL dipstick proteinuria had increased cumulative incidence of ST (hazard rate [HR] 3.69, 95% CI 1.54-8.89), all-cause mortality (HR 2.68, 95% CI 1.34-5.37), and nonfatal MI or death (HR 3.20, 95% CI 1.77-5.81) at 1 year. In addition, estimated GFR of 15 to 59 mL min(-1) 1.73 m(-2) was a significant independent predictor of ST (HR 2.61, 95% CI 1.33-5.10). Dipstick proteinuria > or =30 mg/dL was associated with a trend toward increased risk for all outcomes., Conclusions: In an acute MI population, moderate CKD was identified as a novel prognostic marker for ST. In addition, patients with both decreased GFR and proteinuria had higher incidences of all-cause mortality and nonfatal MI or death than patients with either condition alone.

Background: Concern regarding the rate of delayed acute stent thrombosis associated with drug-eluting stent (DES) treatment has resulted in upward revision of the advised duration of dual antiplatelet therapy after DES implantation by both European and United States guideline writing committees. In fact, the corroboration of an increased rate of late thrombotic events remains outstanding, and these clinical practice guidelines are limited by an inadequate evidence base on which to ground their recommendations., Hypothesis: We postulate that a 6-month duration of clopidogrel therapy after DES implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy., Study Design: The Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) is a multinational, double-blind, placebo-controlled, randomized trial designed to examine the effects of a 6-month duration of clopidogrel therapy after DES implantation compared to that of 12 months. Patients on clopidogrel therapy at 6 months after DES implantation will be randomized in a 1:1 fashion to discontinuation of clopidogrel versus a further 6 months of treatment. The primary end point is a composite of death, myocardial infarction, stent thrombosis, stroke, or thrombolysis in myocardial infarction major bleeding. Clinical follow-up is scheduled at 9 months postrandomization (15 months postintervention). According to power calculations based on a noninferiority design, it is estimated that 6,000 patients are required to be enrolled., Summary: There is clinical equipoise on the issue of optimal duration of dual antiplatelet treatment after percutaneous intervention with DES. The ISAR-SAFE trial aims to assess whether discontinuation of clopidogrel 6 months after DES implantation is noninferior to routine prolongation of such therapy out to 1 year.

Background: Elective intraaortic balloon pump (IABP) may reduce acute complications during unprotected left main (ULM) stenting. However, few data exist on criteria for elective IABP support during ULM stenting., Methods: Since January 1993, 219 consecutive patients underwent elective ULM stenting: 69 had elective IABP support (elective IABP group), whereas 150 patients had conventional procedure (conservative group). Criteria for elective IABP support were (1) lesion located in the distal segment of the left main (bifurcation lesion), (2) left ventricular ejection fraction <40%, (3) atherectomy, (4) unstable angina, and (5) critical disease of the right coronary artery. Incidence of intraprocedural major adverse cardiac events (eg, severe hypotension and/or shock, myocardial infarction, urgent bypass surgery, and death) was assessed., Results: Euroscore >6 (identifying high-risk patients) occurred in 38% in the elective IABP group and 13% in the conservative group (P < .001). Severe hemodynamic instability occurred in 12 patients (8%) in the conservative group and in none in the elective IABP group (P = .020). Intraprocedural major adverse cardiac event was higher in the conservative group (9.5% vs 1.5%, P = .032). Elective IABP support (OR 0.08, 95% CI 0.01-0.69, P = .022) and presence of Euroscore >6 plus bifurcation lesion (OR 5.49; 95% CI 1.47-20.51; P = .011) were the independent predictors of intraprocedural events., Conclusions: Elective IABP may prevent intraprocedural events in elective ULM stenting, especially in patients at higher risk.

Background: Avoiding aortic side clamping is useful to avoid local particulate embolization. A device that allows a saphenous vein graft to be anastomosed to the aorta without aortic manipulation is clinically evaluated., Methods and Results: From July 1999 to March 2000, 17 patients who underwent myocardial revascularization had an aorta-saphenous vein graft anastomosis performed by means of an aortic anastomotic device. Eight were operated on with cardiopulmonary bypass and 9 without. The proximal anastomoses created by the aortic anastomotic device were performed before the institution of cardiopulmonary bypass or before the related distal anastomosis was performed. In 11 patients transcranial Doppler ultrasound was used. In 1 (6%) patient the saphenous vein graft was not deployed, and in 2 (12%) a single suture was added for minor bleeding. None of the 11 patients evaluated with transcranial Doppler ultrasound had evidence of particulate embolization during the procedure. No patient died or was reoperated on for bleeding. Six (35%) patients had a postoperative angiogram 48 +/- 26 days after the operation that showed widely patent proximal anastomoses., Conclusions: Use of an aortic anastomotic device allows a sutureless anastomosis to be created between the aorta and saphenous vein graft. The device could be used in totally endoscopic myocardial revascularization. A second-generation device is ready to solve the problems encountered and to increase the ease in handling the device.

Objectives: The aim of this study was to perform detailed postmortem analysis of bailout coronary stenting to gain insights into the mechanism of success or failure of the procedure. Bailout stenting is increasingly used for acute or threatened arterial closure after angioplasty. Few pathologic data from bailout stenting have been reported., Methods and Results: The coronary arteries from 6 cases of bailout stenting were analyzed at autopsy. All stents were placed for extensive coronary dissection or abrupt vessel closure after balloon angioplasty. Twenty stents (11 Palmaz-Schatz and 9 Gianturco-Roubin stents) were placed in 8 coronary arteries, ranging from 1 to 5 stents per artery. After stenting, angiography showed good coronary flow in 3 of 6 cases. All patients died secondary to acute myocardial infarction. Histologically, in all cases, the stents were well opposed to the coronary artery wall, with a focally widely patent lumen by compression of the dissection plane. However, in 4 of 6 cases, there was residual dissection present in the nonstented portion of the arteries proximal, proximal to, and between stents or distal to the stented segment, resulting in focal luminal compression or obstruction. In 2 cases, bailout stenting effectively covered the dissection and prevented luminal compression., Conclusions: Bailout stenting for dissection after balloon angioplasty restores lumen patency in the stented segment. Residual dissection in nonstented segments adversely affects outcome and supports the need for continued development of new stents with increased trackability and tapering designs to more effectively treat major coronary dissections.

Background: The purpose of this study was to provide an overview on stenting in acute myocardial infarction (MI)., Methods and Results: A search of MEDLINE and the scientific sessions abstracts in peer review journals through May 1998 was carried out to identify any publications on stenting in MI. The settings were retrospective and prospective case series on stenting in MI, nonrandomized and randomized trials comparing primary stenting and primary percutaneous transluminal coronary angioplasty (PTCA) in MI, and stenting in cardiogenic shock complicating MI. Reported outcomes included procedural success, reocclusion, restenosis, and target vessel revascularization rates; incidence of death, MI, recurrent ischemia, major bleeding, and vascular complications; and incidence of cerebrovascular accidents. Procedural success rates were better for stenting than primary PTCA, and postprocedural minimum luminal diameters were larger. This resulted in lower reocclusion and restenosis rates and a lesser need for target vessel revascularization with primary stenting. The incidence of death, MI, and recurrent ischemia was also reduced with primary stenting. Major bleeding and vascular complications were confined to patients receiving anticoagulation as opposed to antiplatelet agents after stenting. Finally, a strategy of bailout stenting for failed PTCA in MI appears to be inferior to a primary stenting strategy., Conclusions: Stenting in MI is an effective and safe reperfusion strategy with many advantages compared with primary PTCA.

Background: The Bard XT stent is a balloon expandable stent with a new design, consisting of discrete zigzag modules welded onto a flexible longitudinal spine., Methods: To assess the safety and efficacy of this recently introduced coronary stent, we studied 81 patients (107 lesions) who underwent implantation of 108 such stents (66% elective)., Results: Primary success in stent delivery was 97.1% and angiographic success was achieved in all cases. Reference segment diameter was 2.69+/-1.4 mm and average lesion length 10.9 mm. Mean minimal luminal diameter before the procedure was 0.79+/-1.11 mm and increased to 2.55+/-1.09 mm after stenting. Diameter stenosis decreased from 76%+/-24% to 9%+/-12%. One Q wave and 1 non-Q-wave myocardial infarction occurred but no other significant complications were observed. At 1-month follow-up, angiographically documented subacute thrombosis occurred in 2 cases at days 1 and 3. Conclusions These preliminary data suggest that the Bard XT stent has a promising design for the safe and effective treatment of coronary lesions, even in the presence of high-risk clinical and unfavorable angiographic characteristics.

Severe calcific atherosclerosis involving the femoral arteries, ascending aorta, right subclavian artery, and aortic arch precluded standard cannulation techniques for a patient requiring emergency revascularization. A cannula was passed from the apex of the left ventricle across the aortic valve to lie in the proximal ascending aorta, and successful cardiopulmonary bypass was achieved to allow revascularization.

A versatile retractor is described that can be used to harvest either mammary artery without disturbing the operative field and can be converted to a standard sternotomy retractor. It uses the principle of elevating the cut sternal edge and applying external pressure to the area of the costochrondal junction to rotate the mammary pedicle into view. We have used this retractor and found it to be very efficient in exposing the mammary pedicle while being atraumatic to the sternum.

Severe atherosclerotic obstructed coronary artery disease (CAD) may preclude passage of a balloon catheter for transluminal coronary angioplasty (TCA). Since lasers have been shown to effectively vaporize CAD plaque, the initial application of laser to effect a lumen large enough to accommodate the angioplasty catheter for further dilatation was explored. Eleven postmortem human CAD segments which did not permit passage of a 1.33 mm shaft diameter angioplasty catheter were studied. Argon laser radiation (14 to 90 J) transmitted via 400 micron core diameter quartz fiber onto the stenotic channel of 0.58 mm created a vaporized lumen of 1.77 mm (mean increase of 1.31 +/- 0.25 mm, p less than 0.001). The laser procedure allowed the balloon angioplasty catheter to be pushed into the stenosis. TCA was then performed (7 atm, 45 seconds) and expanded the channel to 2.12 mm (additional mean increase of 0.38 +/- 0.07 mm, p less than 0.001). In terms of percent luminal narrowing, laser radiation reduced obstruction from 80% to 45% (mean difference of -38.7 +/- 4.6%, p less than 0.001), and TCA caused a further decrease to 37% (mean difference of -9.3 +/- 1.9%, p less than 0.001). Thus, in tight atherosclerotic lesions, the laser may be useful in creating an initial opening enabling the placement of the balloon angioplasty catheter which, in turn, can further dilate the lased stenotic coronary lumen.